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Oral TP-3654 for Myelofibrosis
Study Summary
This trial is to test a new drug for people with a certain type of cancer. The study will see if the drug is safe and if it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I agree to give bone marrow samples at the start and every 6 months during the study.My spleen is enlarged, confirmed by a doctor's exam or imaging tests.You have a peripheral blood blast count of less than 10%.I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.I have tried a JAK inhibitor for my condition without success or cannot use Ruxolitinib or Fedratinib.My electrolyte levels are stable or can be corrected.I haven't had cancer treatment or experimental therapy in the last 14 days or 5 half-lives, whichever is longer.I have had my spleen removed or received spleen radiation in the last 6 months.I do not have any ongoing serious infections needing antibiotics in the last 2 weeks.I am eligible for a bone marrow or stem cell transplant within 3 months after joining.I do not have brain cancer, cancer spread to the brain, or any condition affecting my nervous system.I haven't taken more than 10 mg of steroids daily in the last week.I have taken hydroxyurea or anagrelide in the last 24 hours.I have severe COPD with low oxygen levels.My blood cancer involves more than 10% of certain blood cells.My kidney function is within the required range.I can take care of myself but might not be able to do heavy physical work.I have not had major surgery within the last 2 weeks.I have at least 2 symptoms of my condition that can be measured.I have not had a heart attack or severe heart failure in the last 6 months.My liver functions and blood clotting levels are within the required range.I have tried a JAK inhibitor for my condition and it didn't work or I can't take Ruxolitinib or Fedratinib.My recent tests show significant scarring in my bone marrow.I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.I am on a blood thinner higher than 81mg aspirin or other types.I have had portal hypertension or related complications.I haven't had any cancer except for skin, prostate, or cervical cancer in the last 3 years.I have a condition or had surgery that affects how my body absorbs food.I do not have any ongoing, uncontrolled bleeding issues.I have had a stem cell transplant before.Platelet count ≥ 25 x 10^9/L, without the assistance of growth factors or platelet transfusions.My white blood cell count is healthy without needing medication to help.I can take care of myself but might not be able to do heavy physical work.
- Group 1: TP-3654
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the aggregate figure of participants in this experiment?
"This study necessitates the enrollment of 60 individuals who meet its inclusion requirements. Individuals can become a part of this trial at sites such as University of Virginia Cancer Center in Charlottesville, Virginia and The University of Arizona Cancer Center in Tucson, Arizona."
What is the targeted outcome of this experiment?
"The chief aim of this 28-day medical trial is to gauge the occurrence of treatment-related side effects. Secondary objectives include ascertaining the peak plasma concentration (Cmax) level, determining any changes in QT interval and morphology using Holter ECG monitoring, and noting shifts in patient global impression of change (PGIC) scores at week 24."
Is this project actively gathering participants?
"According to clinicaltrials.gov, recruitment of participants is still ongoing for this medical trial which was published on December 16th 2019 and updated as recently as May 26th 2022."
How many venues are participating in this trial?
"Six centres are executing this clinical trial, including the University of Virginia Cancer Centre in Charlottesville, The University of Arizona Cancer Center in Tucson and Duke Cancer Institute in Durham. An additional three medical institutes across the United States are also participating."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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